The Inspection Readiness Lead provides crucial TMF oversight in collaboration with QA to ensure Inspection Readiness for TMF Portfolio.
Required Skills & Experience
- Collaborate with current TMF Advisor on process improvement and TMF-Quality Oversight
- Liaise with relevant functional leaders regarding responses to audits, inspections and CAPA management associated to TMFs and the management process
- Support inspections and audits, including preparedness and being a point of contact for TMF related questions across the portfolio
- Ensure eTMF specifications for the project are compliant and consistent with program strategy, company standards, and applicable regulatory requirements and guidance
- Provide guidance, clarification, and strategy for regulatory requirements and compliance
- Support study team in addressing/reporting regulatory queries pertaining to document management.
- Conducts gap analysis and develops plans to address deficiencies, may facilitate implementation of plan as well
- Advises on industry trends and regulatory changes that may affect TMF management,
- Designs and develops training, SOPs, and other guidance documents needed to support management of TMF activities
- Process & Compliance
- Workstream support
- Logistics and meeting that support study team deliverables for Inspections
- Collaboration with TMF team for IR support activities
Working Hours – 8am – 4pm EST
- Minimum 5 years of relevant experience in Clinical or TMF Operations oversight
- Experience working with QA department
- Experience in regulatory agency inspections
- Demonstrated awareness of sponsor oversight and TMF
- Experience in management of medical/clinical study records and documentation.
- Experience/knowledge of ICH/GCP documentation requirements.
- Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
- Experience with the following application types: Electronic documentation management systems, web-based data management systems, as required, and database utilization
- Outstanding verbal and written communications skills, combined with outstanding listening skills are required.
- History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
- History of achievement in building strong customer relationships. Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations is very important.
- Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers
Travel Requirements - Ability to travel domestically within U.S. on average up to 10%
Why Work for Phlexglobal?
We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalized career development opportunities.
Our benefits typically include a competitive base salary and generous annual leave. We also provide 401k, medical, dental and vision insurance and life insurance.
Your career and personal development are important to us. We provide you with all the training you need to develop the knowledge and skills to be successful at work. We also provide personalized learning and development plans, and regular performance reviews to enable you to achieve your career development goals.